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NDC 67729-001 Quinine Sulfate

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 67729-001?
  4. Quinine Sulfate Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
67729-001
Proprietary Name:
Quinine Sulfate
Non-Proprietary Name: [1]
Quinine Sulfate
Substance Name: [2]
Quinine Sulfate
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
Pharmakina S.a.
Labeler Code:
67729
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date: [9]
01-01-1961
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
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Product Details

What is NDC 67729-001?

The NDC code 67729-001 is assigned by the FDA to the UNFINISHED product Quinine Sulfate which is a bulk ingredient product labeled by Pharmakina S.a.. The generic name of Quinine Sulfate is quinine sulfate. The product's dosage form is powder. The product is distributed in a single package with assigned NDC code 67729-001-25 25 kg in 1 package . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Quinine Sulfate?

This medication is used alone or with other medication to treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in other body tissues. Both drugs may be needed for a complete cure and to prevent the return of infection (relapse). Quinine belongs to a class of drugs known as antimalarials. It is not used for the prevention of malaria. The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.

What are Quinine Sulfate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • QUININE SULFATE 1 kg/kg - An alkaloid derived from the bark of the cinchona tree. It is used as an antimalarial drug, and is the active ingredient in extracts of the cinchona that have been used for that purpose since before 1633. Quinine is also a mild antipyretic and analgesic and has been used in common cold preparations for that purpose. It was used commonly and as a bitter and flavoring agent, and is still useful for the treatment of babesiosis. Quinine is also useful in some muscular disorders, especially nocturnal leg cramps and myotonia congenita, because of its direct effects on muscle membrane and sodium channels. The mechanisms of its antimalarial effects are not well understood.

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.